Nicotine Dependence
Conditions
Keywords
Tobacco, Smoking, Smoking Cessation, Tobacco Dependence, Tobacco Use, Nicotine Dependence
Brief summary
This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.
Detailed description
* Participants in this study are randomized to one of two treatments conditions prior to a target quit date. * One-half of participants will be randomly assigned to receive standard smoking cessation treatment comprising a 6-week supply of 21-mg nicotine patches and 4 individual smoking cessation counseling sessions. * The other one-half of participants will be randomly assigned to receive standard treatment (patch and counseling, as above) plus to practice quitting 7 times over the 2.5 weeks leading up to a quit attempt. Practice quitting will involve not smoking for a period of time tailored to each individual's smoking pattern. * All participants are asked to attend a 2-hour orientation session, complete 8 brief (5-minute) telephone calls and 9 longer(20-minute) telephone surveys over 3.5 weeks, attend a 30-minute office visit, and complete two 15-minute follow-up calls. * All participants are also asked to report on their emotions, thoughts, and behaviors 3 times per day for 24 days using cellular telephones. * Participants receive compensation for office visits, study telephone calls, cellular telephone reports, and follow-up interviews. * All participants will receive nicotine patches and one-on-one counseling (delivered over the phone and in person). * Some participants will be eligible for a second phase of treatment after a 4-week follow-up interview. * One-half of people eligible for this phase of the study will be randomly assigned to receive a supply of non-nicotine cigarettes to smoke for up to 6 weeks. The non-nicotine cigarettes are designed to help break the habit of smoking and to help smokers return to being smoke-free after smoking regular cigarettes. * The other one-half of eligible smokers will be randomly assigned to not receive these non-nicotine cigarettes. * All smokers eligible for this phase of the study will be asked to complete cellular telephone reports about their mood, thoughts, and behaviors for 14 days beginning 4.5 weeks after a target stop-smoking date. Compensation will be provided for completing these cellular telephone phone reports.
Interventions
BEHAVIORALStandard treatment
Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
BEHAVIORALStandard treatment+practice quitting
This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
This intervention will be offered to a subset of smokers from both of the other study arms. To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above. Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
Sponsors
National Institute on Drug Abuse (NIDA)
Rutgers University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Smoke cigarettes daily * Motivated to quit smoking * Able to read and write English * Willing and able to complete study visits and cell phone calls
Exclusion criteria
* Pregnancy, breastfeeding, planning on becoming pregnant during the study * Recent heart attack or heart surgery, heart disease, unstable angina * Allergy to adhesives * Past negative reactions to nicotine patch * Serious skin conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4-week Abstinence | 4 weeks | 7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-week Abstinence | 10 weeks | This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million. |
| Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date | 3 weeks pre-quit | Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident. |
| Prolonged Abstinence | 10 weeks | This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between June 12, 2012 and May 24, 2013 through community-wide recruitment including direct mail, flyers, and radio advertising.
Pre-assignment details
Randomization was in 2 phases; 1: participants who met inclusion/exclusion criteria were randomized to either standard treatment or standard treatment plus practice quitting; in phase 2, smokers who smoked between weeks 3 and 4 post-quit were randomly assigned to either receive advice only, or advice plus very low nicotine cigarettes.
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking | 47 |
| Standard Treatment+Practice Quitting In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling | 46 |
| Total | 93 |
Baseline characteristics
| Characteristic | Total | Standard Treatment | Standard Treatment+Practice Quitting |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 45 Participants | 45 Participants |
| Age, Continuous | 47.76 years STANDARD_DEVIATION 12.44 | 47.13 years STANDARD_DEVIATION 14.27 | 48.41 years STANDARD_DEVIATION 10.36 |
| Region of Enrollment United States | 93 participants | 47 participants | 46 participants |
| Sex: Female, Male Female | 48 Participants | 24 Participants | 24 Participants |
| Sex: Female, Male Male | 45 Participants | 23 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 47 | 22 / 46 | 10 / 20 | 13 / 20 |
| serious Total, serious adverse events | 3 / 47 | 4 / 46 | 2 / 20 | 1 / 20 |
Outcome results
Primary
4-week Abstinence
7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Treatment | 4-week Abstinence | Smoking (any cigarettes in past 7 days) | 29 participants |
| Standard Treatment | 4-week Abstinence | Lost to 4-week follow-up | 3 participants |
| Standard Treatment | 4-week Abstinence | Abstinent (no smoking reported in past 7 days) | 15 participants |
| Standard Treatment+Practice Quitting | 4-week Abstinence | Abstinent (no smoking reported in past 7 days) | 17 participants |
| Standard Treatment+Practice Quitting | 4-week Abstinence | Smoking (any cigarettes in past 7 days) | 20 participants |
| Standard Treatment+Practice Quitting | 4-week Abstinence | Lost to 4-week follow-up | 9 participants |
Secondary
10-week Abstinence
This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.
Time frame: 10 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Treatment | 10-week Abstinence | Abstinent (no smoking past 7 days) CO-confirmed | 5 participants |
| Standard Treatment | 10-week Abstinence | Lost to 10-week follow-up | 6 participants |
| Standard Treatment | 10-week Abstinence | Smoking (any cigarettes in past 7 days) | 36 participants |
| Standard Treatment+Practice Quitting | 10-week Abstinence | Abstinent (no smoking past 7 days) CO-confirmed | 11 participants |
| Standard Treatment+Practice Quitting | 10-week Abstinence | Lost to 10-week follow-up | 9 participants |
| Standard Treatment+Practice Quitting | 10-week Abstinence | Smoking (any cigarettes in past 7 days) | 26 participants |
| Very Low Nicotine Cigarettes | 10-week Abstinence | Smoking (any cigarettes in past 7 days) | 17 participants |
| Very Low Nicotine Cigarettes | 10-week Abstinence | Abstinent (no smoking past 7 days) CO-confirmed | 2 participants |
| Very Low Nicotine Cigarettes | 10-week Abstinence | Lost to 10-week follow-up | 1 participants |
| Advice and Encouragement Only | 10-week Abstinence | Abstinent (no smoking past 7 days) CO-confirmed | 1 participants |
| Advice and Encouragement Only | 10-week Abstinence | Lost to 10-week follow-up | 0 participants |
| Advice and Encouragement Only | 10-week Abstinence | Smoking (any cigarettes in past 7 days) | 19 participants |
Secondary
Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date
Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident.
Time frame: 3 weeks pre-quit
Population: Participants who quit for at least 1 day in the first 2 weeks after the target quit date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date | 4.39 units on a scale | Standard Error 0.14 |
| Standard Treatment+Practice Quitting | Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date | 3.70 units on a scale | Standard Error 0.22 |
Secondary
Prolonged Abstinence
This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.
Time frame: 10 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Treatment | Prolonged Abstinence | Lost to 10-week follow-up | 6 participants |
| Standard Treatment | Prolonged Abstinence | Abstinent (no smoking 7 days in a row) | 14 participants |
| Standard Treatment | Prolonged Abstinence | Smoking (7 days in a row) | 27 participants |
| Standard Treatment+Practice Quitting | Prolonged Abstinence | Smoking (7 days in a row) | 17 participants |
| Standard Treatment+Practice Quitting | Prolonged Abstinence | Abstinent (no smoking 7 days in a row) | 20 participants |
| Standard Treatment+Practice Quitting | Prolonged Abstinence | Lost to 10-week follow-up | 9 participants |
| Very Low Nicotine Cigarettes | Prolonged Abstinence | Lost to 10-week follow-up | 1 participants |
| Very Low Nicotine Cigarettes | Prolonged Abstinence | Abstinent (no smoking 7 days in a row) | 1 participants |
| Very Low Nicotine Cigarettes | Prolonged Abstinence | Smoking (7 days in a row) | 18 participants |
| Advice and Encouragement Only | Prolonged Abstinence | Smoking (7 days in a row) | 14 participants |
| Advice and Encouragement Only | Prolonged Abstinence | Abstinent (no smoking 7 days in a row) | 6 participants |
| Advice and Encouragement Only | Prolonged Abstinence | Lost to 10-week follow-up | 0 participants |